[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630565":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":10,"responsibleParty":26,"collaborators":10,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":34,"eligibilityCriteria":35,"healthyVolunteers":30,"sex":36,"minAge":37,"maxAge":10,"enrollmentInfo":38,"targetDuration":41,"studyType":42,"phases":10,"briefSummary":43,"conditions":44,"keywords":46,"overallStatus":51,"whyStopped":10,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":10},{"fullName":5,"class":6},"SetPoint Medical Corporation","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SetPoint System users",null,"Patients indicated for the SetPoint System in whom the implant procedure for the SetPoint System has been attempted",[13],"Device: SetPoint System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","SetPoint System","implanted, vagus-mediated neuroimmune modulator for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response, loss of response or intolerance to one or more biological or targeted synthetic disease modifying antirheumatic drugs (b\u002FtsDMARDs)",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Vickie Haines","CONTACT","661-750-6140","vhaines@setpointmedical.com",{"type":27,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100630565","the-setpoint-system-safety--performance-post-approval-study-100630565",false,"NCT07489326","The SetPoint System Safety & Performance Post-Approval Study","The SetPoint System Safety & Performance Post-Approval Study (ACTIVATE Study)","ACTIVATE","Inclusion Criteria:\n\n* Indicated for the SetPoint System\n* Implant procedure for the SetPoint System has been attempted\n* Willing to sign Informed Consent Form\n\nExclusion Criteria:\n\n* Contraindicated for the SetPoint System","ALL","22 Years",{"count":39,"type":40},150,"ESTIMATED","3 Years","OBSERVATIONAL","Prospective, multicenter, post-market, registry study designed to systematically collect real-world data (RWD) from participants implanted with the SetPoint System \\[implanted, vagus-mediated, neuroimmune modulator\\] for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). The registry will assess adherence to surgical training, device performance, system usability, safety, and clinical outcomes as reported in clinical practice.",[45],"Rheumatoid Arthritis",[45,47,48,49,50],"Vagus nerve","vagus nerve stimulating device","permanent implantable","implant","NOT_YET_RECRUITING","2026-03-19",{"date":54,"type":55},"2026-03-24","ACTUAL",{"date":57,"type":40},"2026-04-15",{"date":59,"type":40},"2031-01-01",{"name":5,"class":6}]